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Lipitor (Atorvastatin Calcium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, LIPITOR can be started simultaneously with diet.


Prevention of Cardiovascular Disease

In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, LIPITOR is indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke
  • Reduce the risk for revascularization procedures and angina

In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, LIPITOR is indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke

In patients with clinically evident coronary heart disease, LIPITOR is indicated to:

  • Reduce the risk of non-fatal myocardial infarction
  • Reduce the risk of fatal and non-fatal stroke
  • Reduce the risk for revascularization procedures
  • Reduce the risk of hospitalization for CHF
  • Reduce the risk of angina

Hypeerlipidemia

LIPITOR is indicated:

  • As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
  • As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);
  • For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
  • To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
  • As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
      LDL-C remains ≥ 190 mg/dL or
    • LDL-C remains ≥ 160 mg/dL and: there is a positive family history of premature cardiovascular disease or
    • two or more other CVD risk factors are present in the pediatric patient

Limitations of Use

LIPITOR has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

DOSAGE AND ADMINISTRATION

2.1).

Recommended start dose: 10 or 20 mg once daily (2.1).

Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily (2.1).

Pediatric starting dose: 10 mg once daily; maximum recommended dose: 20 mg once daily (2.2).


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Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)

The recommended starting dose of LIPITOR is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once daily. LIPITOR can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of LIPITOR should be individualized according to patient characteristics such as goal of therapy and response (see current NCEP Guidelines). After initiation and/or upon titration of LIPITOR, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10–17 years of age)

The recommended starting dose of LIPITOR is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see current NCEP Pediatric Panel Guidelines, Clinical Pharmacology , and Indications and Usage ]. Adjustments should be made at intervals of 4 weeks or more.

Homozygous Familial Hypercholesterolemia

The dosage of LIPITOR in patients with homozygous FH is 10 to 80 mg daily. LIPITOR should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Concomitant Lipid-Lowering Therapy

LIPITOR may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions, Skeletal Muscle, Drug Interactions (7) ].

Dosage in Patients With Renal Impairment

Renal disease does not affect the plasma concentrations nor LDL-C reduction of LIPITOR; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions, Skeletal Muscle, Clinical Pharmacology, Pharmacokinetics ].

Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or a Combination of Ritonavir plus Saquinavir or Lopinavir plus Ritonavir

In patients taking cyclosporine, therapy should be limited to LIPITOR 10 mg once daily. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of ritonavir plus saquinavir or lopinavir plus ritonavir, for doses of LIPITOR exceeding 20 mg, appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPITOR is employed [see Warnings and Precautions, Skeletal Muscle, Drug Interactions (7) ].

DOSAGE FORMS AND STRENGTHS

White, elliptical, film-coated tablets containing 10, 20, 40, and 80 mg atorvastatin calcium.

HOW SUPPLIED/STORAGE AND HANDLING

10 mg tablets: coded "PD 155" on one side and "10" on the other.

Bottles of 10
NDC 54868-3934-3
Bottles of 30
NDC 54868-3934-0
Bottles of 45
NDC 54868-3934-4
Bottles of 60
NDC 54868-3934-2
Bottles of 90
NDC 54868-3934-1


20 mg tablets: coded "PD 156" on one side and "20" on the other.

Bottles of 15 NDC 54868-3946-1
Bottles of 30
NDC 54868-3946-0
Bottles of 45
NDC 54868-3946-4
Bottles of 60
NDC 54868-3946-3
Bottles of 90
NDC 54868-3946-2


40 mg tablets: coded "PD 157" on one side and "40" on the other.

Bottles of 15
NDC 54868-4229-2
Bottles of 30
NDC 54868-4229-0
Bottles of 45
NDC 54868-4229-3
Bottles of 90
NDC 54868-4229-1


80 mg tablets: coded "PD 158" on one side and "80" on the other.

Bottles of 15
NDC 54868-4934-3
Bottles of 30
NDC 54868-4934-0
Bottles of 45
NDC 54868-4934-1
Bottles of 90
NDC 54868-4934-1

Store at controlled room temperature 20 – 25°C (68 – 77°F) [see USP].

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